Dr. Naruse is a section manager of the PMDA Office of Cellular and Tissue-based Products. She is in charge of quality review/consultation of biopharmaceuticals and approval review /consultation of biosimilar products. She has been in the office since 2020. She joined PMDA in 2005 after 11 years of QA and QA experience at a pharmaceutical company. She was mainly involved in inspecting biopharmaceutical manufacturing facilities as a GMP inspector. She served as a manager of the GMP inspection Division from 2013 to 2020. During her tenure as a manager of GMP division, she participated in the development of guidelines for GMP and GCTP in MHLW Science Research, and considered various guidance based on regulatory science.